NCT03473132

Assessment of Coagulation Factor Levels in Left Ventricular Device (LVAD )Patients Following Temporary Warfarin Reversal With Four Factor Prothrombin Complex Concentrate (4F-PCC)

Assessment of Coagulation Factor Levels in LVAD Patients Following Temporary Warfarin Reversal With 4F-PCC

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prospective assessment of vitamin K dependent coagulation factor levels after temporary warfarin reversal in participants with left ventricular assist devices (LAVD).

Detailed description

Prospective evaluation of the levels of the vitamin K dependent coagulation factors 2,7,9,10, and proteins C and S, in patients on warfarin treated with four factor prothrombin complex concentrate (4F-PCC). Participants on vitamin K antagonists (VKA) such as warfarin have suppressed levels that are brought to the normal range with treatment with 4F-PCC to reverse the warfarin effect. The investigators will assess the duration of effect of 4F-PCC on these factor levels in participants with left ventricular assist devices (VAD) requiring temporary reversal of warfarin for invasive procedures that have a risk of bleeding. The investigators will also assess the time to return to therapeutic INR..

Conditions

• Anticoagulation
• Anticoagulation Reversal

Interventions

Type	Name	Description
DRUG	four factor prothrombin complex concentrate	After treatment with 4F-PCC, coagulation factor levels will be assessed. Time to return to anticoagulation target INR will also be determined.

Timeline

• Start date: 2018-03-15
• Primary completion: 2021-12-31
• Completion: 2022-03-31
• First posted: 2018-03-22
• Last updated: 2021-05-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study